Clinical trial · Interventional
Metformin in Combination With Standard Induction Therapy for Large B-cell Lymphoma (DLBCL)
A Phase ll Study Evaluating the Efficacy and Safety of Metformin in Combination With Standard Induction Therapy (RM-CHOP) for Previously Untreated Aggressive Diffuse Large B-cell Lymphoma
NCT02531308CI-TRIAL-00061082DLBCLterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
Evaluation of impact of metformin on 2 year progression-free survival (PFS) rate in subjects with previously untreated DLBCL when added to standard induction therapy. (R-CHOP)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Metformin | Drug | Metformin | ALIAS |
| pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-CHOP with Metformin
- description
- Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study. Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.
- interventionNames
- Drug: Metformin
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: pegfilgrastim
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 2 year
- description
- rate of progression in patients 2 years after diagnosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Diagnosis of Diffuse Large B-cell Lymphoma (DLBCL) as documented by medical records and with histology based on criteria established by the World Health Organization
a. subtyping is required for DLBCL
2. No prior therapy for diagnosis of DLBCL
3. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of equal to or greater than 1 lesion that measures \>1.5 cm in the longest diameter and \> 1.0 cm in the longest perpendicular diameter assessed by CT or MRI) or bone marrow involvement
4. Eastern Cooperative Oncology Group performance score of 0-2
5. Life expectancy of at least 6 months
6. No history of medication dependent diabetes mellitus
7. Required screening laboratory data (within 4 weeks prior to start of study drug) -
Exclusion Criteria:
1. Patients already on any class of anti-diabetic medication including metformin, insulin analogues, sulfonylureas, thiazolidinediones (TZDs) and the incretin-based therapies or clear need for therapeutic intervention based on fasting blood glucose
2. Known histological transformation from indolent non-Hodgkins Lymphoma (NHL) or chronic lymphocytic leukemia (CLL) to an aggressive form of NHL (ie, Richter transformation)
3. Double or triple hit lymphomas
4. Known active cent4ral nervous system or leptomeningeal lymphoma
5. Presence of known intermediate or high-grade myelodysplastic syndrome
6. History of a non-lymphoid malignancy within the last 3 years (see protocol for exceptions)
7. Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study
8. Ongoing, drug-induced liver injury, chronic active Hepatitis C Virus (HCV), chronic active Hepatitis B Virus (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
9. HIV positive
10. Ongoing inflammatory bowel disease
11. Ongoing alcohol or drug addiction
12. Pregnancy
13. History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
\-References
Publications (0)
Data not yet available
No reference posted for this study.